Amorphous Solid Dispersions: Development Trends, Challenges and the Future
The pharmaceutical industry is pushing the boundaries of the chemical drug space in search of new and more effective compounds. However, many of these new molecules have properties that make them difficult to develop, including challenging physiochemical characteristics. As a result, the number of poorly soluble drugs in the pipeline is increasing, and there is…
Read MoreOverview: KinetiSol Technology from AustinPx
The KinetiSol™ Technology generates amorphous solid dispersions, dramatically improving the bioavailability of poorly soluble drugs. KinetiSol is a fusion-based, solvent-free process that utilizes frictional and shear energies – in a fraction of the time of other ASD technologies. With its significantly smaller ecological footprint, broader formulation design space, faster processing times and wider application to…
Read MoreAustinPx Live Episode 6: Re-thinking ASD Development: Designing for Scale from Day One
Originally aired on March 18th, 2026 Chief Technology Officer, Chris Brough, Ph.D., will lead a discussion on what it takes to successfully scale amorphous solid dispersions from early development into manufacturing. He will explore common scale-up challenges across ASD technologies, the data and decisions that matter most as programs move toward GMP, and how early…
Read MoreAustinPx Live Episode 5: Re-thinking ASD Development: When Your Molecule Breaks the Rules
Originally aired on January 22nd, 2026 Chief Scientific Officer, Dave Miller, Ph.D., will explore how KinetiSol™ is reshaping the design space for amorphous solid dispersions (ASDs). He’ll break down how our solvent-free platform enables rapid screening, broader excipient use, and higher-performing formulations compared to conventional technologies like spray drying or HME. The session will also…
Read MoreAustinPx Live Episode 4: From Brick Dust to Breakthrough: The Power of Enabled Formulation
Originally aired on October 22nd, 2025 Join us for our fourth episode of AustinPx Live where Chief Scientific Officer, Dave Miller, Ph.D., will share how AustinPx uses enabling formulation strategies to advance molecules once considered too complex to develop. He’ll highlight how our expertise with KinetiSol™, polymer and excipient screening, and biopharm-guided design-of-experiments creates formulations…
Read MoreOvercoming Late Stage Formulations & Manufacturing Challenges with KinetiSol Technology
In this Xtalks webinar, Dr. Dave Miller, Chief Scientific Officer at AustinPx, explores how KinetiSol™ Technology helps sponsors overcome the formulation and manufacturing hurdles that often appear late in development. Traditional spray drying methods can introduce variability, high costs, and scale-up challenges, but KinetiSol offers a solvent-free alternative that delivers consistent performance and improved manufacturability.…
Read MoreDe-Risking Development: Guiding Formulation Strategy with MacroFlux to Predict Human Outcomes of KinetiSol-Processed Etravirine
KinetiSol™ Technology enables formulation of poorly soluble compounds, but predicting human performance remains a key challenge in early development. In this session, Daniel Davis, Ph.D. (Director of Business Development, AustinPx), presents a case study on developing a generic equivalent for Intelence (Etravirine) using MacroFlux™ to establish in-vitro/in-vivo correlation and optimize formulation strategy. By linking dissolution…
Read MoreHow Difficult Is it to Scale Up an Amorphous Dispersion? (Xtalks interview)
In this Xtalks interview, Dr. Justin Keen, Senior Vice President of Operations at AustinPx, explained why scale up is one of the biggest challenges in amorphous dispersion manufacturing and how KinetiSol™ solves it. Traditional technologies like spray drying and hot melt extrusion require controlling multiple transport phenomena at once, which slows timelines and increases cost. KinetiSol…
Read MoreOral Dosage Innovation for Pediatric Drug Delivery
Pediatric drug development isn’t just about reducing adult doses. It involves unique technical, regulatory, and manufacturing challenges that require creative formulation strategies. In this webinar, experts from AustinPx and Via Therapeutics explore the complex development of clofazimine mini-tablets for pediatric use, covering solubility issues, stability hurdles, and process optimization from early formulation through clinical manufacturing.…
Read MoreOptimizing Drug Loading in Amorphous Solid Dispersions: Maximizing Bioavailability While Minimizing Pill Burden
Amorphous solid dispersions (ASDs) have revolutionized drug delivery by enhancing the bioavailability of poorly soluble drugs. However, formulators often assume that higher drug loading in ASDs will automatically reduce pill burden by minimizing excipient content. This approach overlooks a critical factor: increasing the drug-to-polymer ratio can significantly reduce the fraction of drug absorbed, ultimately leading to…
Read MoreOptimizing Amorphous Solid Dispersions: Overcoming Scale-Up Challenges with Next-Generation Technologies
As the number of poorly soluble molecules entering the pipeline has increased, the application of amorphous solid dispersions development has grown. With the advent of next-generation ASD technologies, like KinetiSol Technology, drug developers are setting new standards in scalability, sustainability and performance. In this webinar, the expert speakers will share their scale-up experiences and perspectives on opportunities to…
Read MoreWhy KinetiSol Technology is Disrupting Spray Drying
Dave Miller, AustinPx CSO’s (Chief Scientific Officer) talk begins by showcasing two case studies of commercial spray dried dispersions— replicated with KinetiSol and eliminating toxic solvents, manufacturing complexity, and improving drug product properties. Springboarding from these case studies, Dave then focuses on the facility, utilities, and downstream processing requirements for SDDs and contrasts those with…
Read MoreKinetiSol Technology: Scale-Up Approach
Justin Keen, AustinPx Sr. VP of Operations’ talk begins with a discusion on phase-appropriate process development objectives, reviewed as they relate to scale and mode changes as product development evolves to deliver clinical trial material and develop the process design space. Process parameter and quality attribute relationships, including those for typical pre and post KinetiSol…
Read MoreData-Driven Development of Clofazimine: A High-Drug Load Pediatric Mini-Tablet
The development of clofazimine pediatric mini-tablets demonstrates a data-driven approach to pharmaceutical development. By leveraging predictive tools and iterative design, AustinPx transformed a formulation-challenged compound into a scalable, patient-friendly product suitable for clinical trials.
Read MoreKinetiSol in Action: Scalable, Sustainable Amorphous Dispersion Manufacturing
See the KinetiSol Compounder in action and learn how AustinPx’s proprietary KinetiSol™ Technology supports amorphous solid dispersion (ASD) development from rapid prototyping through commercial manufacturing. This video highlights how KinetiSol’s solvent-free, fusion-based process forms ASDs in seconds, simplifies scale-up, reduces operational burden, and expands the formulation design space for complex molecules. With a focus on scalability,…
Read MoreRedefining Drug-Like Properties with KinetiSol
Christopher Lipinski’s Rule of Five (Ro5) has been used for nearly three decades to evaluate whether a compound possesses the chemical and physical properties to potentially be an orally active drug in humans. But have modern molecules and technologies rendered Lipinski’s guidelines irrelevant? The KinetiSol process accommodates high-temperature melters without issue and solvent solubility is irrelevant to…
Read MoreFormulation Strategies for Enabling “Undevelopable” Compounds (Poster)
Many modern drug candidates fall outside traditional guidelines like Lipinski’s Rule of Five, making them difficult to formulate with conventional technologies. This poster, presented by Dave Miller at DDC (2025) and the PECK Symposium (2025), highlights how KinetiSol™ was used to formulate a poorly soluble compound with multiple developability challenges—including high dose, poor solubility, and low…
Read MoreTailoring Exposure for Efficacy: Next Generation PK Optimization with KinetiSol-Enabled BAE and CR Design
Many drug candidates require more than solubility enhancement to achieve optimal therapeutic performance. This presentation from Dave Miller at CRBE Summit West (2026) explores how KinetiSol™ Technology can be used to tailor pharmacokinetic (PK) profiles through advanced amorphous solid dispersion (ASD) design. Using a tetrabenazine case study, the presentation highlights how KinetiSol enabled a modified…
Read MoreUsing KinetiSol Technology to Improve an Abandoned Prostate Cancer Medication (Galeterone)
In 2019, there were approximately 175,000 new cases of prostate cancer, contributing to 10% of male cancer-related fatalities. Galeterone, a novel prostate cancer candidate treatment, was discontinued after a Phase III clinical trial due to lack of efficacy. This Case Study explores how KinetiSol outperforms Spray Dried ASD and helped bring Galeterone to market.
Read MoreConverting from a Spray-Dried Dispersion to a KinetiSol Formulation in <5 Months
A Phase 2 oral drug candidate formulated as a spray-dried dispersion faced limitations in bioavailability, pill burden, and solvent-intensive manufacturing. In less than five months, AustinPx converted the program to a KinetiSol™ formulation, achieving a 5x increase in AUC, reducing manufacturing time by 67%, and eliminating organic solvents and secondary processing steps. The result was…
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